(28 days)
Not Found
No
The description focuses on the hardware and basic image capture/display functionality. There is no mention of AI/ML terms, image processing beyond display, or any analysis of the image data by the device itself.
No
The device is described as an endoscopic diagnosis tool used for visualization, indicating a diagnostic rather than therapeutic purpose.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "ATMOS Scope is used for endoscopic diagnosis." The "Device Description" also mentions it is "for endoscopic diagnosis" and "The endoscopic image is used for visual diagnostics by the user."
No
The device description explicitly details hardware components such as a handle, flexible steerable part, deflection lever, integrated LED light sources, image sensor, and electronics built into the handle. It is an electrical device with mechanical components for manipulation and image capture.
Based on the provided information, the ATMOS Scope is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "endoscopic diagnosis within the nasal lumens and airway anatomy" and to "provide visualization via a monitor." This describes a device used for direct visualization of internal body structures.
- Device Description: The description details a flexible endoscope with a camera and light source for generating a digital image of the anatomy. This is consistent with an endoscopic device.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis. The ATMOS Scope is used inside the body for direct visualization.
Therefore, the ATMOS Scope falls under the category of an endoscopic device for direct visualization, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ATMOS Scope is used for endoscopic diagnosis within the nasal lumens and airway anatomy and is intended to provide visualization via a monitor. The ATMOS Scope may only be used by persons with an appropriate medical qualification and who are acquainted with the rhino/laryngoscopic technique.
Product codes (comma separated list FDA assigned to the subject device)
EOB
Device Description
The ATMOS Scope is a flexible nasopharyngo laryngoscope for endoscopic diagnosis within the nasal lumens and airway anatomy.
The device is an electrical device and consists of a handle for the user and a flexible, steerable part that is inserted into the patient. The deflection lever can be easily operated with the thumb and enables precise control of the endoscope tip at an angle of 2 x 135°. This makes it easy to examine even hard-to-reach regions in the nose, or throat.
The device contains two integrated LED light sources that provide bright and homogeneous illumination in the complete field of view. With the help of a 1280 x 800-pixel image sensor at the flexible part and the electronics built into the handle, a digital image is generated.
For taking and saving photos and videos, the ATMOS Scope has two separate function keys located directly on the handle. This can be displayed as the endoscopic image on a connected PC with video software. The endoscopic image is used for visual diagnostics by the user.
The ATMOS Scope is delivered in a non-sterile condition.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal lumens and airway anatomy
Indicated Patient Age Range
Patients for whom an endoscopic examination is generally indicated. The use of the device also depends on the patient's general condition and must therefore be critically evaluated by the responsible physician before each use.
Intended User / Care Setting
persons with an appropriate medical qualification and who are acquainted with the rhino/laryngoscopic technique.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Human factors testing: The human factors testing is conducted regarding to the dimensions of the applied part (length and diameter and deflection/angle measurement) and the particular requirements for the basic safety and essential performance of endoscopic equipment according to the standard IEC 60601-2-18 were successfully tested.
Optical performance test and photobiological safety of lamp system: An evaluation according to the standard IEC 62471:2006 was conducted and the used LEDs were classified in risk group 2. Additionally, due to the integrated optical light range of the LED is limited. Summarized all aspects considered and the measurements prove that the photobiological safety of the ATMOS Scope product is guaranteed and there is no risk as well as no hazard from the light source.
Sterilization validation: Both sterilization processes were validated by EN ISO 14937 (Annex D), AAMI TIR 12, and ANSI/AAMI ST79 and can be optionally conducted after one of the reprocessing methods. First sterilization process is using a Low-Temperature Hydrogen Peroxide Gas Sterilization Method. The second validated sterilization method is performed in the SYSTEM 1E Liquid Chemical Sterilant Processing System with standard liquid chemical sterilization (LCS) cycles using S40 Sterilant.
Biocompatibility evaluation: Biocompatibility evaluation of subject device ATMOS Scope was performed to comply with the specifications as per standard ISO 10993-1:2018 as well as the FDA Guidance Documents and the effectiveness of the biocompatibility of the ATMOS Scope.
Reprocessing Testing: The reprocessing method consists of a cleaning process conducted and validated by AAMI TIR 30: 2011 and a high-level disinfection process conducted and validated by ASTM E 1837-96 (2014). The manual cleaning process can be conducted by using the Dual enzymatic cleaning detergent MetriZyme (MetriSPONGE; company Metrex) or Cidezyme (ASP) and the manual high-level disinfection process by using the ready-to-use solution CIDEX OPA (ASP).
Electrical safety and electromagnetic compatibility (EMC): To ensure safe operation of ATMOS Scope, tests were performed according to IEC 60601-1:2005. All clauses of this standard are evaluated and assessed in the corresponding risk assessment file. To measure the ability of ATMOS Scope to function satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbance to anything in that environment, Electromagnetic Compatibility Test according to IEC 60601-1-2 Edition 4.0 2014-02 was performed. With a risk-based approach required tests and acceptance criteria were defined.
Software Verification and Validation: Embedded software does not provide support for basic safety or essential performance. Failure of the software does not lead to a risk, therefore PEMS (IEC 60601-1 section 14) does not apply. Every firmware function was validated, and the requirements traceability matrix was documented to prove that requirements have been fulfilled. Digital image after generation can be displayed on a connected PC with any video software. Due to this requirement the USB connection was checked regarding their configuration, USB device name "ATMOS Scope" and used live image broadcast according to the USB Video Device Class Specification. Summarized all tests regarding to the firmware were passed successfully.
Key Results: Non-clinical, simulated use and human factors testing were performed to compare the performance of the subject device and the predicate device using identical inputs. Testing results demonstrated that the performance of the subject device is equivalent to the predicate device for each software, electrical and mechanical design specification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 3, 2023
ATMOS MedizinTechnik GmbH & Co. KG Reinhold Storch Manager Projects & Technical Editing ENT/GYNE/FEES Ludwig-Kegel-Str. 16 Lenzkirch, BW 79853 Germany
Re: K232015
Trade/Device Name: ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOB Dated: April 7, 2023 Received: July 6, 2023
Dear Reinhold Storch:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the name "Joyce C. Lin -S" in a simple, sans-serif font. The text is black against a background that appears to be white. The letters are clear and legible, with consistent spacing between them. The overall impression is clean and professional.
for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K232015
Device Name
ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)
Indications for Use (Describe)
ATMOS Scope is used for endoscopic diagnosis within the nasal lumens and airway anatomy and is intended to provide visualization via a monitor. The ATMOS Scope may only be used by persons with an appropriate medical qualification and who are acquainted with the rhino/laryngoscopic technique.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/1 description: The image contains the logo for ATMOS MedizinTechnik. The logo features the word "ATMOS" in a bold, sans-serif font, arranged in an arc shape. Below the word "ATMOS" is the word "MedizinTechnik" in a smaller, sans-serif font. The color of the logo is blue.
510(k) Summary
Submitter:
Contact Person:
ATMOS MedizinTechnik GmbH & Co. KG
Dr. Reinhold Storch ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str. 16 79853 Lenzkirch / Germany Phone: + 49 7653 689-647 Email: regulatory@atmosmed.de
ATMOS Scope (507.7000.0) ATMOS Scope Pro (507.7050.0) ATMOS Scope iPrime (507.7060.0)
21 CFR 874.4760
Ear, Nose & Throat
Class II
EOB
Nasopharyngoscope (Flexible Or Rigid)
Date Prepared:
28.07.2023
Device
Name of Device:
Classification Name: Regulation: 510(k): Device Classification: Medical Specialty: Device Product Code:
Predicate device
Predicate Manufacturer: Predicate Trade Name: Predicate 510(k): Device Product Code:
Schoelly Fiberoptic GmbH Schoelly CMOS Video Nasopharyngoscope System K143673 EOB
Device Description
The ATMOS Scope is a flexible nasopharyngo laryngoscope for endoscopic diagnosis within the nasal lumens and airway anatomy.
The device is an electrical device and consists of a handle for the user and a flexible, steerable part that is inserted into the patient. The deflection lever can be easily operated with the thumb and enables precise control of the endoscope tip at an angle of 2 x 135°. This makes it easy to examine even hard-to-reach regions in the nose, or throat.
The device contains two integrated LED light sources that provide bright and homogeneous illumination in the complete field of view. With the help of a 1280 x 800-pixel image sensor at the flexible part and the electronics built into the handle, a digital image is generated.
For taking and saving photos and videos, the ATMOS Scope has two separate function keys located directly on the handle. This can be displayed as the endoscopic image on a connected PC with video software. The endoscopic image is used for visual diagnostics by the user.
The ATMOS Scope is delivered in a non-sterile condition.
Indication for use
ATMOS Scope is used for endoscopic diagnosis within the nasal lumens and airway anatomy and is intended to provide visualization via a monitor. The ATMOS Scope may only be used by persons with an appropriate medical qualification and who are acquainted with the rhino/laryngoscopic technique.
Intended patient target group
Patients for whom an endoscopic examination is generally indicated. The use of the device also depends on the patient's general condition and must therefore be critically evaluated by the responsible physician before each use.
4
Image /page/4/Picture/1 description: The image shows the logo for ATMOS MedizinTechnik. The logo features the word "ATMOS" in a bold, sans-serif font, with the letters arranged in a slightly curved manner. The word "MedizinTechnik" is written in a smaller, sans-serif font below the word "ATMOS".
Comparison of technological characteristics with the predicate device
The following characteristics were compared between the subject device and the predicate device to demonstrate substantial equivalence:
| Similarities | |||||
|---|---|---|---|---|---|
| Feature | Subject Device | Predicate Device | |||
| ATMOS Scope | K143673 | ||||
| Indications for Use | ATMOS Scope is used for | ||||
| endoscopic diagnosis within | |||||
| the nasal lumens and airway | |||||
| anatomy and is intended to | |||||
| provide visualization via a | |||||
| monitor. The ATMOS Scope | |||||
| may only be used by persons | |||||
| with an appropriate medical | |||||
| qualification and who are | |||||
| acquainted with the | |||||
| rhino/laryngoscopic technique. | The Schoelly CMOS Video | ||||
| Nasopharyngoscope System | |||||
| may only be used by persons | |||||
| with appropriate medical | |||||
| qualifications and who are | |||||
| acquainted with the | |||||
| rhino/laryngoscopic technique. | |||||
| The endoscope is used for | |||||
| endoscopic diagnosis within | |||||
| the nasal lumens and airway | |||||
| anatomy and is intended to | |||||
| provide visualization via a | |||||
| video monitor. | |||||
| Design | Flexible and steerable | ||||
| fiberoptic endoscope for | |||||
| diagnostic purposes | Flexible and steerable | ||||
| fiberoptic endoscope for | |||||
| diagnostic purposes | |||||
| Material | The handle is made of | ||||
| aluminum (hard anodized and | |||||
| coated) with a multifunctional | |||||
| surface coating. The insertion | |||||
| tube is made of PEEK, FKM, | |||||
| TPU, and sapphire glass. | The handle is made of | ||||
| aluminium (hard anodized and | |||||
| coated) with a multifunctional | |||||
| surface coating. The insertion | |||||
| tube is made of PEEK, FKM, | |||||
| TPU, and sapphire glass. | |||||
| Chip-on-Tip | Chip-on-Tip technology | ||||
| integrated: CMOS image | |||||
| sensor at the tip of the insertion | |||||
| tube | Chip-on-Tip technology | ||||
| integrated: CMOS image | |||||
| sensor at the tip of the insertion | |||||
| tube | |||||
| Lightning | LED (2 LEDs) | LED (2 LEDs) | |||
| Deflection | 2 x 135° | 2 x 135° | |||
| Weight | 0,4 kg | 0,4 kg | |||
| USB Connection | Yes | Yes | |||
| Focus Range | 6 - 60 mm | 6 – 60 mm | |||
| Delivery Status (Sterilization) | None-sterile | None-sterile |
Table 1 Similarities between a subject device and predicate device
5
510(k) Submission – ATMOS Scope 510(k) Summary
Image /page/5/Picture/1 description: The image contains the logo for ATMOS MedizinTechnik. The logo features the word "ATMOS" in a bold, sans-serif font, with the letters arranged in a slightly curved manner. Above the word is a blue circular shape that partially encloses the text. Below the word "ATMOS" is the word "MedizinTechnik" in a smaller, sans-serif font.
| Differences | |||
|---|---|---|---|
| Feature | Subject Device | ||
| ATMOS Scope | Predicate Device | ||
| K143673 | Justification | ||
| Image | |||
| Sensor | |||
| Resolution of | |||
| the image | |||
| sensor | |||
| (Pixel) | 1/14.25" CMOS | ||
| 1280 x 800 | |||
| 800 x 800 (640.000) | 1/18" CMOS | ||
| 328 x 250 | |||
| 328 x 250 (82.000) | CMOS sensors are | ||
| installed as image sensors | |||
| for both subject device as | |||
| well as predicate device. | |||
| These provide images of | |||
| different resolutions. In | |||
| comparison with the | |||
| predicate device, the | |||
| effective resolution of the | |||
| ATMOS Scope is higher | |||
| (resulting from the | |||
| combination of its slightly | |||
| larger field of view and the | |||
| higher pixel number of its | |||
| image sensor). The higher | |||
| resolution provides an | |||
| optimized view of the | |||
| anatomy. Therefore, the | |||
| aspect "safety and | |||
| effectiveness" is not | |||
| impacted negatively due | |||
| the different image | |||
| resolution with the ATMOS | |||
| Scope. | |||
| Connection | |||
| to PC | Connection to PC via USB | ||
| (control and video signal), | |||
| control of LEDs and buttons. | The device handle shall be | ||
| connected to the CCU. | |||
| CCU can be connected to | |||
| the PC via USB (control | |||
| functions and video signal), | |||
| monitor via s-video (video | |||
| signal), and stroboscope. | |||
| Internal control of LEDs and | |||
| button action. | Both, subject device as | ||
| well as predicate device | |||
| are using a USB | |||
| connector. While K143673 | |||
| requires a control unit to | |||
| be connected, ATMOS | |||
| Scopes can be connected | |||
| directly to the PC. This | |||
| does not change the risk | |||
| for the patient. | |||
| Field of view | 90° | 85° | In comparison with the |
| predicate device, the | |||
| effective resolution of the | |||
| ATMOS Scope is higher | |||
| (resulting from the | |||
| combination of its slightly | |||
| larger field of view and the | |||
| higher pixel number of its | |||
| image sensor). The larger | |||
| field of view provides an | |||
| optimized view of the | |||
| anatomy. Therefore, the | |||
| aspect "safety and | |||
| effectiveness" is not | |||
| impacted negatively due | |||
| the difference in the field of | |||
| view with the ATMOS | |||
| Scope. | |||
| Stroboscopy | Not supporting stroboscopy | stroboscopy | This feature removed from |
| subject device due to | |||
| patient complaints in | |||
| K143673. | |||
| Sterilization | |||
| (optional) | The ATMOS Scope with | ||
| attachment for pressure | |||
| compensation can be sterilized | |||
| by using a Low-Temperature | |||
| Hydrogen Peroxide Gas | |||
| Sterilization Method. This | |||
| sterilization process can be | |||
| optionally conducted after one | |||
| of the reprocessing methods. | |||
| The following parameter of the | |||
| sterilization processes are | |||
| validated: H2O2 Concentration | |||
| [mg/L]: 16 | |||
| Plasma power [W]: 350W | |||
| Cycle Duration [min]: 58 | |||
| Deep Vacuum [mTorr]: 275 | |||
| The second validated | |||
| sterilization method is | |||
| performed in the SYSTEM 1E® | |||
| Liquid Chemical Sterilant | |||
| Processing System with | |||
| standard liquid chemical | |||
| sterilization (LCS) cycles using | |||
| S40® Sterilant. | Flexible Schoelly endoscope | ||
| with air-exhaust can also be | |||
| gas sterilized using ethylene | |||
| oxide | |||
| Specification: Gas mixture | |||
| 6% Eto, 94% CO2 | |||
| Temperature 131°F+/-5°F, | |||
| 55°C+/-2°C | |||
| Relative air humidity 40-90% | |||
| Pressure (overpressure), | |||
| 17bar (17kpa) | |||
| Exposure time 120 mins | Validation tests were | ||
| performed according to | |||
| FDA recognized standards | |||
| and Guidance to provide | |||
| performance data in | |||
| support of the substantial | |||
| equivalence determination: | |||
| Reprocessing | The manual reprocessing | ||
| method consists of the manual | |||
| cleaning process by using the | |||
| Dual enzymatic cleaning | |||
| detergent MetriZymeTM | |||
| (MetriSPONGE; company | |||
| Metrex) or Cidezyme (ASP®) | |||
| and the manual high-level | |||
| disinfection process by using | |||
| the ready-to-use solution | |||
| CIDEX® OPA (ASP®) for 18 | |||
| minutes at a minimum | |||
| temperature of 20°C. | Place the endoscope and the | ||
| unscrewed parts in a suitable | |||
| disinfection solution (which | |||
| can also double up as a | |||
| cleaning solution used | |||
| should be permitted by the | |||
| manufacturer for such use, | |||
| Material compatibility release | |||
| exist for the following | |||
| disinfectants | |||
| • Gigasept FF, Schulke & | |||
| Maye GmbH | |||
| • Lysetol FF | |||
| • Helipur HplusN, B Braun | |||
| Medical AG | |||
| • Cidex, Johnson & Johnson | Validation tests were | ||
| performed according to | |||
| FDA recognized standards | |||
| and Guidance to provide | |||
| performance data in | |||
| support of the substantial | |||
| equivalence determination |
6
510(k) Submission - ATMOS Scope 510(k) Summary K232015
Image /page/6/Picture/1 description: The image shows the logo for ATMOS MedizinTechnik. The logo consists of the word "ATMOS" in blue, with the "A" stylized to have a point at the top. The word "MedizinTechnik" is written in black below the logo. The logo is surrounded by a blue circle.
Table 2 Differences between a subject device and predicate device
The technological differences do not raise different questions of safety and effectiveness.
Performance data
The following performance data were provided in support of the substantial equivalence determination.
Human factors testing
The human factors testing is conducted regarding to the dimensions of the applied part (length and diameter and deflection/angle measurement) and the particular requirements for the basic safety and essential performance of endoscopic equipment according to the standard IEC 60601-2-18 were successfully tested.
7
Image /page/7/Picture/1 description: The image shows the logo for Atmos MedizinTechnik. The logo consists of the word "ATMOS" in blue, with the letters arranged in a semi-circular shape. Below the word "ATMOS" is the word "MedizinTechnik" in black, with the first letter of each word capitalized.
Optical performance test and photobiological safety of lamp system
An evaluation according to the standard IEC 62471:2006 was conducted and the used LEDs were classified in risk group 2. Additionally, due to the integrated optical light range of the LED is limited. Summarized all aspects considered and the measurements prove that the photobiological safety of the ATMOS Scope product is guaranteed and there is no risk as well as no hazard from the light source.
Sterilization validation
Both sterilization processes were validated by EN ISO 14937 (Annex D), AAMI TIR 12, and ANSI/AAMI ST79 and can be optionally conducted after one of the reprocessing methods. First sterilization process is using a Low-Temperature Hydrogen Peroxide Gas Sterilization Method. The second validated sterilization method is performed in the SYSTEM 1E® Liquid Chemical Sterilant Processing System with standard liquid chemical sterilization (LCS) cycles using S40® Sterilant.
Biocompatibility evaluation
Biocompatibility evaluation of subject device ATMOS Scope was performed to comply with the specifications as per standard ISO 10993-1:2018 as well as the FDA Guidance Documents and the effectiveness of the biocompatibility of the ATMOS Scope.
Reprocessing Testing
The reprocessing method consists of a cleaning process conducted and validated by AAMI TIR 30: 2011 and a high-level disinfection process conducted and validated by ASTM E 1837-96 (2014). The manual cleaning process can be conducted by using the Dual enzymatic cleaning detergent MetriZymeTM (MetriSPONGE; company Metrex) or Cidezyme (ASP®) and the manual high-level disinfection process by using the ready-to-use solution CIDEX® OPA (ASP®).
Electrical safety and electromagnetic compatibility (EMC)
To ensure safe operation of ATMOS Scope, tests were performed according to IEC 60601-1:2005. All clauses of this standard are evaluated and assessed in the corresponding risk assessment file. To measure the ability of ATMOS Scope to function satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbance to anything in that environment, Electromagnetic Compatibility Test according to IEC 60601-1-2 Edition 4.0 2014-02 was performed. With a risk-based approach required tests and acceptance criteria were defined.
Software Verification and Validation
Embedded software does not provide support for basic safety or essential performance. Failure of the software does not lead to a risk, therefore PEMS (IEC 60601-1 section 14) does not apply. Every firmware function was validated, and the requirements traceability matrix was documented to prove that requirements have been fulfilled.
Digital image after generation can be displayed on a connected PC with any video software. Due to this requirement the USB connection was checked regarding their configuration, USB device name "ATMOS Scope" and used live image broadcast according to the USB Video Device Class Specification. Summarized all tests regarding to the firmware were passed successfully.
Labelling
All labeling and documentation associated with the ATMOS Scope are in compliance with 5-117 AAM ANSI ISO 15223-1 3rd edition 2016-11-01, Medical Devices - Symbols To Be Used With Medical Devices Labels, Labeling, And Information To Be Supplied - Part 1: General Requirements. This is not subject to test requirements and no test report is provided.
Conclusion
Non-clinical, simulated use und human factors testing were performed to compare the performance of the subject device and the predicate device using identical inputs. Testing results demonstrated that the
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Image /page/8/Picture/1 description: The image shows the logo for ATMOS Medizintechnik. The logo features the word "ATMOS" in a bold, sans-serif font, arranged in an arc shape. A blue circle surrounds the word "ATMOS". Below the word "ATMOS" is the word "MedizinTechnik" in a smaller, sans-serif font.
performance of the subject device is equivalent to the predicate device for each software, electrical and mechanical design specification.
A risk analysis was completed, and risk controls were implemented. Human factors testing was conducted to demonstrate that the ergonomics of patient and user interfaces for the subject device are equivalent to the predicate device.
Based upon the intended use, descriptive information, and performance evaluation provided the ATMOS Scope is substantially equivalent to the currently marketed predicate device K143673.